Secondary HIV Prevention and Adherence Among HIV-infected Drug Users

NCT01741311 | Completed Results DMC

• 2 other identifiers: H12-050R01DA032290
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test whether 3H+ (Holistic Health for HIV) is comparable to the original HHRP+ (Holistic Health Recovery Program) in reducing HIV risk behaviors and improving ART (Antiretroviral Therapy) adherence in a randomized controlled comparative effectiveness trial among 256 HIV+ persons in drug treatment who report unsafe injection drug use practices or sexual risk behavior.

Conditions

Risk Behavior; Medication Adherence; HIV

Keywords

viral load; HIV; CD4; methadone maintenance; substance use; Antiretroviral therapy (ART)

Outcome Measures

Primary Outcomes (1)

• Number of Participants in Each Condition With Optimal ART Adherence

  Anti-retroviral therapy (ART) adherence was assessed by self-report using the visual analogue scale (VAS). The VAS measures adherence continuously from 0 to 100%, with higher scores indicating better adherence to the medication. A greater number of participants with optimal ART adherence is better. Optimal ART adherence is defined as a score \>95% on the visual analog scale (VAS).

  Assessed at post-intervention, 3-months, & 6-months. Reported in the table at 6-months.

Secondary Outcomes (1)

• Viral Suppression

  Assessed at post-intervention, 3-months, & 6-months. Reported in the table at 6-months.

Study Arms (2)

3H+ Group

EXPERIMENTAL

3H+ (Holistic for HIV) group patients will receive the standard of drug treatment care (i.e., methadone maintenance treatment and case management) plus four weekly 60-minute HIV risk reduction groups, and a 60-minute booster session at 12 weeks, led by two facilitators trained and supervised by a licensed clinical psychologist. 3H+ is an HIV risk reduction and ART adherence intervention that provides coping skills training and is delivered in a group modality, addressing high risk drug- and sex-related HIV risk behaviors and ART adherence for opioid-dependent individuals living with HIV.

Behavioral: 3H+ (Holistic Health for HIV)

HHRP+ Group

ACTIVE COMPARATOR

HHRP+ (Holistic Health Recovery Program) is comprised of 12 two-hour weekly manual-guided group sessions with comprehensive HIV risk reduction content that addresses the medical, emotional, and spiritual needs of opioid-dependent individuals living with HIV. Each session is designed to last 2 hours and is co-facilitated by two trained facilitators, who address potential motivational conflicts of HIV+ individuals by providing them with self-protective as well as altruistic reasons for examining and changing their HIV risk behaviors and improving adherence behavior. Material is presented using cognitive remediation strategies.

Behavioral: HHRP+ (Holistic Health Recovery Program)

Interventions

3H+ (Holistic Health for HIV) BEHAVIORAL

Four weekly HIV-risk reduction groups and an additional booster group held at week twelve summarizing the previous sessions' content, designed for opioid-dependent individuals living with HIV.

3H+ Group

HHRP+ (Holistic Health Recovery Program) BEHAVIORAL

12 two-hour group sessions addressing HIV risk reduction behavior and recovery for opioid-dependent individuals living with HIV.

HHRP+ Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV positive
• Opioid dependent and enrolled in methadone maintenance treatment
• Report drug- or sex-related HIV risk behavior in previous 6 months
• Able to read and understand the questionnaires, the Audio Computer Assisted Self Interview (ACASI), and consent form
• Available for the full duration of the study with no anticipated circumstances impeding participation
• Not actively suicidal, homicidal, or psychotic as assessed by trained research staff under the supervision of the PI who is a licensed clinical psychologist in Connecticut.

Sponsors & Collaborators

• University of Connecticut: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Yale University: collaborator
• APT Foundation, Inc.: collaborator

Study Sites (1)

APT Foundation

New Haven, Connecticut, 06511, United States

Location

Related Publications (2)

• Avants SK, Margolin A, Usubiaga MH, Doebrick C. Targeting HIV-related outcomes with intravenous drug users maintained on methadone: a randomized clinical trial of a harm reduction group therapy. J Subst Abuse Treat. 2004 Mar;26(2):67-78. doi: 10.1016/S0740-5472(03)00159-4.

  PMID: 15050083 BACKGROUND

• Margolin A, Avants SK, Warburton LA, Hawkins KA, Shi J. A randomized clinical trial of a manual-guided risk reduction intervention for HIV-positive injection drug users. Health Psychol. 2003 Mar;22(2):223-8.

  PMID: 12683743 BACKGROUND

Related Links

• University of Connecticut Center for Health, Intervention, and Prevention (CHIP)

MeSH Terms

Conditions

Risk-Taking; Medication Adherence; Substance-Related Disorders

Interventions

Holistic Health; Seroconversion

Condition Hierarchy (Ancestors)

Behavior; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Health; Population Characteristics; Immune System Phenomena

Results Point of Contact

• Title: Michael Copenhaver
• Organization: University of Connecticut

michael.copenhaver@uconn.edu

8602083632

Study Officials

• Michael C Copenhaver, Ph.D.

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 4, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 8, 2025
• Results First Posted: August 8, 2025

Record last verified: 2025-08

Locations

US (1)